Agency Terminates Buvanest Drug Permit After Deaths
Jakarta. The Food and Drug Monitoring Agency, known as BPOM, has terminated the distribution permit for the drug Buvanest Spinal by state-controlled pharmaceutical firm Kalbe Farma due to non-compliance with good manufacturing practices.
“[Kalbe Farma’s] investigation report did not adequately depict the problem roots, that there can be a potential mix-up,” said Togi Junice Hutadjulu, director of therapeutic products monitoring at the agency, on Thursday.
Preliminary findings from the ongoing investigation suggest Kalbe Farma incorrectly labelled tranexamic acid as Buvanest Spinal, which resulted in the deaths of two women undergoing Caesarian section and cystoscopy procedures at Siloam Hospital in Tangerang last month.
Investor Daily
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